In late February, CDER launched a new web education series called “CDER World,” designed to inform international regulators as well as health care professionals and the public about its drug review processes and its mission.
Course module content is based on that used by CDER at its Forum for International Drug Regulatory Authorities – a meeting between FDA and international regulators that has been held twice yearly since 2005. The meetings are held to help the regulators learn first-hand how CDER organizes its drug review process and carries out its mission.
Each module contains a self-guided computer-based lecture, followed by a multiple choice “knowledge check.” After successful completion of the knowledge check in each module, a certificate documenting that completion is granted.
The site currently contains modules on compliance, generic drugs and new drugs, covering the associated agency office structures and review activities.
New modules will be posted as they are developed. The next module planned will cover drug safety.
As part of its effort to support innovation, advance regulatory science and make its review processes more transparent, FDA is also establishing a small business liaison. The liaison will to work with its product centers to help companies navigate the FDA approval process (IPQ “The News in Depth” February 26).